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NCT02684591 · ClinicalTrials.gov registry record · Phase 2
Aramchol for HIV-associated Nonalcoholic Fatty Liver Disease and Lipodystrophy
A Phase 2 study, sponsored by University of California, San Diego.
- Completed
- Registry status
- Phase 2
- Development phase
- 50
- Enrollment target
NCT02684591 is a Phase 2 study that has completed, run by University of California, San Diego. The registered enrollment target is 50 participants.
The verdict
NCT02684591, a Phase 2 study, has completed, sponsored by University of California, San Diego.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 50 participants
- Enrollment target
Study Summary
A subset of patients with NAFLD that have not been extensively studied are those infected with human immunodeficiency virus (HIV). Currently, there is no FDA approved treatment for NAFLD or NASH. Additionally, there have been no significant clinical trials for HIV patients with NAFLD and there are no approved treatment options. We plan to conduct a randomized, double-blinded, placebo-controlled clinical trial to examine the efficacy of 600 mg of Aramchol daily (including 200 mg tablet and 400 mg tablet) versus identical placebo given over 12 weeks to improve HIV-associated hepatic steatosis as measured by a validated and accurate magnetic resonance imaging (MRI)-based technique.
Interventions
- DRUG Placebo
- DRUG Aramchol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2016-01 |
| Est. Completion | 2018-02 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02684591
The ClinicalTrials.gov registry entry for NCT02684591 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, San Diego, which has 775 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02684591 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02684591 about?
NCT02684591 is a clinical study titled "Aramchol for HIV-associated Nonalcoholic Fatty Liver Disease and Lipodystrophy". A subset of patients with NAFLD that have not been extensively studied are those infected with human immunodeficiency virus (HIV). Currently, there is no FDA approved treatment for NAFLD or NASH. Additionally, there have been no significant clinical trials for HIV patients with NAFLD and there are n...
What is the current status of trial NCT02684591?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 50 participants. The study started on 2016-01. Estimated completion is 2018-02.
What interventions are being tested in trial NCT02684591?
The interventions under investigation include: Placebo (DRUG), Aramchol (DRUG).
Who is sponsoring clinical trial NCT02684591?
This trial is sponsored by University of California, San Diego, which has 775 total clinical trials registered on ClinicalTrials.gov.
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